Flulaval Adverse Reaction

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, observer-blind, active, comparator-controlled immunogenicity and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses, depending on vaccination history, of FLULAVAL QUADRIVALENT 0.5 mL (n=1207) or Fluzone Quadrivalent 0.25 mL (n=1217). Subjects were followed for safety for 6 months; solicited local and systemic adverse reactions were collected for 7 days (day of vaccination and the next 6 days).1